Evoke Pharma announced positive topline results from their comparative exposure pharmacokinetic study.
Evoke Pharma (NASDAQ:EVOK) announced positive topline results from their comparative exposure pharmacokinetic (PK) study.
As quoted in the press release:
The trial was designed to demonstrate that a proposed dose of Gimoti, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has similar systemic exposure to that of the referenced listed drug (RLD), Reglan Tablets. Based on the results, the Company will submit a 505(b)(2) New Drug Application (NDA) with a selected Gimoti dose to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.
The PK study was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence. Following discussions at pre-NDA meetings with FDA, Evoke planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (AUC) falling within the bioequivalence range of 80-125% of the RLD.